# K042727: Pocket Size Resuscitator/Model: M16201R and M16201A

- Pathway: 510(k) (Traditional)
- Applicant: Foremount Ent. Co., Ltd.
- Decided: Mar 18, 2005 after 168 days
- Product code: CBP (Valve, Non-Rebreathing)
- Device class: 2
- Regulation: 21 CFR 868.5870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K081516: Medsource CPR Mask with & Without Oxygen Port (2008), 5 descendants of its own
- K112126: Genuine First Aid CPR Mask (2011), 2 descendants of its own
- K142764: KYOLING CPR Mask with Oxygen Port and Without Oxygen Port (2015), 1 descendant of its own
- K171961: Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm) (2017), 0 descendants of its own
- K102299: CPR Face Mask (2011), 0 descendants of its own

## Indications for use
The Foremount Pocket Size Resuscitator / Model M16201R is indicated for use of mouth to mask ventilation via the ventilation mask with non-rebreathing valve for adult and child whose weight exceeds 10kg. The resuscitator with oxygen port is for prescription use. The Foremount Pocket Size Resuscitator / Model M16201A is indicated for use of adult mouth to mask ventilation via the ventilation mask with non-rebreathing valve for and child whose weight exceeds 10kg. The resuscitator without oxygen port is for over-the-counter use.

Source page: https://510kreport.com/device/K042727
Methodology: https://510kreport.com/methodology